Efficacy of Ramelteon in Subjects With Chronic Insomnia

February 27, 2012 updated by: Takeda

A Phase 3, Open-label, Fixed-dose Study to Determine the Safety of Long-term Administration of TAK-375 in Subjects With Chronic Insomnia

The purpose of this study is to determine the long-term safety of Ramelteon, once daily (QD), in subjects with chronic insomnia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Insomnia is characterized by difficulties initiating and maintaining sleep or complaints of non-restorative and non-refreshing sleep. Transient insomnia affects approximately one-third to one-half of the US population, based on the results of 2 surveys of representative samples of the adult US population conducted by the Gallup Organization in which respondents were asked if they had "ever had difficulty sleeping." Based on reports of "regular" or "frequent" sleep difficulty, results from the same studies suggest that approximately one-tenth of the US population experiences chronic insomnia. The ideal treatment for insomnia would reduce the latency to onset of sleep and increase total sleep time, without a negative impact on sleep architecture and without safety concerns or next-day effects.

Ramelteon is selective melatonin-1 receptor agonist under global development by Takeda Chemical Industries, Ltd., for the treatment of transient and chronic insomnia and for the treatment of Circadian Rhythm Sleep Disorders.

The purpose of this study is to obtain data in support the safety of long-term use of Ramelteon for insomnia, and to determine whether there are any adverse effects associated with extended use. Participation in this study is expected to be about. Participation in this study is anticipated to be approximately 13 months.

Study Type

Interventional

Enrollment (Actual)

1213

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States
      • Mobile, Alabama, United States
    • Arizona
      • Phoenix, Arizona, United States
      • Tempe, Arizona, United States
    • Arkansas
      • Hot Springs, Arkansas, United States
      • Little Rock, Arkansas, United States
    • California
      • Anaheim, California, United States
      • Burbank, California, United States
      • Cerritos, California, United States
      • Irvine, California, United States
      • La Jolla, California, United States
      • La Mesa, California, United States
      • Lafayette, California, United States
      • Murrieta, California, United States
      • Newport Beach, California, United States
      • Northridge, California, United States
      • Redlands, California, United States
      • Riverside, California, United States
      • San Diego, California, United States
      • San Francisco, California, United States
      • Santa Monica, California, United States
    • Colorado
      • Boulder, Colorado, United States
      • Colorado Springs, Colorado, United States
      • Denver, Colorado, United States
      • Pueblo, Colorado, United States
      • Wheat Ridge, Colorado, United States
    • Delaware
      • Wilmington, Delaware, United States
    • Florida
      • Brandon, Florida, United States
      • Clearwater, Florida, United States
      • Deland, Florida, United States
      • Edgewater, Florida, United States
      • Fort Lauderdale, Florida, United States
      • Largo, Florida, United States
      • Miami, Florida, United States
      • Naples, Florida, United States
      • New Smyrna Beach, Florida, United States
      • Ocala, Florida, United States
      • Safety Harbor, Florida, United States
      • St. Petersburg, Florida, United States
      • Stuart, Florida, United States
      • Tampa, Florida, United States
      • Winter Park, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
      • Austell, Georgia, United States
      • Blairsville, Georgia, United States
      • Macon, Georgia, United States
    • Idaho
      • Boise, Idaho, United States
    • Illinois
      • Chicago, Illinois, United States
      • Elk Grove Village, Illinois, United States
      • Libertyville, Illinois, United States
      • Skokie, Illinois, United States
    • Indiana
      • Evansville, Indiana, United States
      • Fort Wayne, Indiana, United States
    • Kansas
      • Shawnee Mission, Kansas, United States
    • Kentucky
      • Florence, Kentucky, United States
      • Louisville, Kentucky, United States
      • Paducah, Kentucky, United States
    • Louisiana
      • New Orleans, Louisiana, United States
      • Shreveport, Louisiana, United States
    • Maryland
      • Baltimore, Maryland, United States
      • Bryan Pogue, Maryland, United States
      • Chevy Chase, Maryland, United States
      • Frederick, Maryland, United States
      • Prince Frederick, Maryland, United States
      • Rockville, Maryland, United States
    • Massachusetts
      • Newton, Massachusetts, United States
    • Michigan
      • Ann Arbor, Michigan, United States
      • Troy, Michigan, United States
    • Minnesota
      • Minneapolis, Minnesota, United States
    • Mississippi
      • Hattiesburg, Mississippi, United States
    • Missouri
      • St. Louis, Missouri, United States
      • St. Peters, Missouri, United States
      • Wentzville, Missouri, United States
    • Montana
      • Billings, Montana, United States
    • Nebraska
      • Lincoln, Nebraska, United States
    • Nevada
      • Las Vegas, Nevada, United States
    • New Jersey
      • Clementon, New Jersey, United States
      • Lawrenceville, New Jersey, United States
      • Newark, New Jersey, United States
      • Toma River, New Jersey, United States
    • New York
      • Brooklyn, New York, United States
      • Kingston, New York, United States
      • Lake Success, New York, United States
      • Rochester, New York, United States
      • White Plains, New York, United States
      • Williamsville, New York, United States
    • North Carolina
      • Cary, North Carolina, United States
      • Raleigh, North Carolina, United States
      • Salisbury, North Carolina, United States
      • Wilmington, North Carolina, United States
      • Winston-Salem, North Carolina, United States
    • Ohio
      • Beachwood, Ohio, United States
      • Cincinnati, Ohio, United States
      • Columbus, Ohio, United States
      • Dublin, Ohio, United States
      • Toledo, Ohio, United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
    • Oregon
      • Eugene, Oregon, United States
      • Portland, Oregon, United States
    • Pennsylvania
      • Bala Cynwyd, Pennsylvania, United States
      • Duncansville, Pennsylvania, United States
      • Jenkintown, Pennsylvania, United States
      • Lafayette Hill, Pennsylvania, United States
      • Philadelphia, Pennsylvania, United States
    • Rhode Island
      • Warwick, Rhode Island, United States
    • South Carolina
      • Anderson, South Carolina, United States
      • Columbia, South Carolina, United States
      • Greer, South Carolina, United States
    • Tennessee
      • Bristol, Tennessee, United States
      • Cordova, Tennessee, United States
    • Texas
      • Austin, Texas, United States
      • Houston, Texas, United States
      • Plano, Texas, United States
      • San Antonio, Texas, United States
    • Utah
      • Salt Lake City, Utah, United States
    • Virginia
      • Charlottesville, Virginia, United States
      • Fairfax, Virginia, United States
    • Washington
      • Oakland, Washington, United States
      • Seattle, Washington, United States
      • Tacoma, Washington, United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States
      • Wauwatosa, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  • Participant has participated in an allowed Ramelteon study and has completed all final visit procedures for the previous study within 21 days of the Treatment Initiation Visit for this study.
  • Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
  • Investigator believes that participant requires long-term treatment for insomnia.
  • Primary insomnia as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition Revised for at least 3 months and a history of daytime complaint(s) associated with disturbed sleep.
  • Subjective sleep latency greater than or equal to 45 minutes and a subjective total sleep time less than or equal to 6.5 hours per night for at least 3 nights during the week of the Baseline Lead-in Period.
  • Habitual bedtime is between 8:30PM and 12:00AM.
  • Body mass index between 18 and 34, inclusive.

Exclusion Criteria

  • Known hypersensitivity to Ramelteon or related compounds, including melatonin.
  • Participated in any other investigational study, and/or taken any investigational drug within 30 days or five half-lives prior to Day 1 of study medication, whichever is longer. The only exception to this is prior participation in an allowed Ramelteon study.
  • Sleep schedule changes required by employment (eg, shift worker) within three months prior to Day 1 of study medication, or has flown across greater than three time zones within seven days prior to screening.
  • Participated in a weight loss program or has substantially altered their exercise routine within 30 days prior to Day 1 of study medication.
  • Ever had a history of seizures, sleep apnea, chronic obstructive pulmonary disease, restless leg syndrome, schizophrenia, bipolar disorder, mental retardation, or cognitive disorder.
  • History of psychiatric disorder (including anxiety or depression) within the past 12 months.
  • History of drug addiction or drug abuse with the past 12 months.
  • History of alcohol abuse within the past 12 months, as defined in the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition Revised and/or regularly consumes 4 or more alcoholic drinks per day.
  • Current significant neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematologic, or metabolic disease, unless currently controlled and stable with protocol-allowed medication 30 days prior to Day 1 of study medication.
  • Uses tobacco products during nightly awakenings.
  • Any clinically important abnormal finding as determined by a medical history, physical examination, electrocardiogram, or clinical laboratory tests, as determined by the investigator.
  • Positive hepatitis panel.

  • Any additional condition(s) that in the Investigator's opinion would:

    • affect sleep/wake function
    • prohibit the subject from completing the study, or
    • not be in the best interest of the subject to participate in the study.
  • Morning serum cortisol at the Baseline visit of less than 7.0 micro-g per dl.

  • Is required to take or continues taking any disallowed medication, prescription medication, herbal treatment or over-the counter medication, including:

    • Anxiolytics
    • Hypnotics
    • Antidepressants
    • Anticonvulsants
    • Sedating H1 antihistamines
    • Systemic steroids
    • Respiratory stimulants (eg, theophylline)
    • Decongestants
    • Over-the-counter and prescription stimulants
    • Over-the-counter and prescription diet aids
    • Central nervous system active drugs
    • Narcotic analgesics
    • Beta blockers
    • St. John's Wort
    • Kava-kava
    • Gingko biloba
    • Melatonin

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ramelteon 8 mg QD
Drug: Ramelteon
Subjects 65 yrs of age and older will take Ramelteon 8 mg, tablets, orally, once nightly for up to one year.
Other Names:
  • Rozerem
  • TAK-375
Drug: Ramelteon
Subjects between 18 and 64 years of age will take Ramelteon 16 mg, tablets, orally, once nightly for up to one year.
Other Names:
  • Rozerem
  • TAK-375
Experimental: Ramelteon 16 mg QD
Drug: Ramelteon
Subjects 65 yrs of age and older will take Ramelteon 8 mg, tablets, orally, once nightly for up to one year.
Other Names:
  • Rozerem
  • TAK-375
Drug: Ramelteon
Subjects between 18 and 64 years of age will take Ramelteon 16 mg, tablets, orally, once nightly for up to one year.
Other Names:
  • Rozerem
  • TAK-375

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse Events.
Time Frame: Week 1, Months 1, 2, 3, 4, 6, 8, 10, and 12 or Final Visit.
Week 1, Months 1, 2, 3, 4, 6, 8, 10, and 12 or Final Visit.
Change from Baseline in Vital Signs.
Time Frame: Week 1, Months 1, 2, 3, 4, 6, 8, 10, and 12 or Final Visit
Week 1, Months 1, 2, 3, 4, 6, 8, 10, and 12 or Final Visit
Change from Baseline in Hematology Laboratory Tests.
Time Frame: Week 1, Months 1, 2, 4, 6, 8, 10, and 12 or Final Visit.
Week 1, Months 1, 2, 4, 6, 8, 10, and 12 or Final Visit.
Change from Baseline in Chemistry Laboratory Tests.
Time Frame: Week 1, Months 1, 2, 4, 6, 8, 10, and 12 or Final Visit.
Week 1, Months 1, 2, 4, 6, 8, 10, and 12 or Final Visit.
Change from Baseline in Urinalysis Laboratory Tests.
Time Frame: Week 1, Months 1, 2, 4, 6, 8, 10, and 12 or Final Visit.
Week 1, Months 1, 2, 4, 6, 8, 10, and 12 or Final Visit.
Electrocardiograms.
Time Frame: Month 6 and 12 or Final Visit.
Month 6 and 12 or Final Visit.
Menstrual Diary Results.
Time Frame: Week 1, Months 1, 2, 4, 6, 8, 10, and 12 or Final Visit.
Week 1, Months 1, 2, 4, 6, 8, 10, and 12 or Final Visit.
Physical Examinations.
Time Frame: Months 2, 4, 8, 10, and 12 or Final Visit.
Months 2, 4, 8, 10, and 12 or Final Visit.

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in Subjective Total Sleep Time.
Time Frame: Week 1, Months 1, 2, 3, 4, 6, 8, 10, 12, and 12 or Final Visit.
Week 1, Months 1, 2, 3, 4, 6, 8, 10, 12, and 12 or Final Visit.
Change from Baseline in Subjective Sleep Latency.
Time Frame: Week 1, Months 1, 2, 3, 4, 6, 8, 10, 12, and 12 or Final Visit.
Week 1, Months 1, 2, 3, 4, 6, 8, 10, 12, and 12 or Final Visit.
Clinical Global Impression Scale.
Time Frame: Months 6 and 12 or Final Visit.
Months 6 and 12 or Final Visit.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Takeda

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2003

Primary Completion (Actual)

September 1, 2004

Study Completion (Actual)

September 1, 2004

Study Registration Dates

First Submitted

May 1, 2008

First Submitted That Met QC Criteria

May 1, 2008

First Posted (Estimate)

May 5, 2008

Study Record Updates

Last Update Posted (Estimate)

February 28, 2012

Last Update Submitted That Met QC Criteria

February 27, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01-02-TL-375-022
  • U1111-1114-3372 (Registry Identifier: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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